摘要
目的：比较单用曲妥珠单抗与曲妥珠单抗和拉帕替尼两药联合在 HER2阳性乳腺癌新辅助治疗中的有效性和安全性。方法检索 PubMed、MEDLINE、The Cochrane Library、Web of Science、中国期刊全文数据库、万方医药期刊全文数据库和近5年重要国际肿瘤学会议记录，严格按照纳入与排除标准收集 HER2阳性乳腺癌患者使用新辅助化疗联合曲妥珠单抗对比新辅助化疗联合曲妥珠单抗、拉帕替尼双重抗 HER2治疗的有效性和安全性的前瞻性随机对照研究，按 Cochrane 系统评价方法进行质量评价，资料提取后运用 Rev-Man 5.0软件进行 Meta 分析。结果最终纳入4项临床随机对照试验，共779例患者符合条件。Meta分析结果显示，曲妥珠单抗联合拉帕替尼组较单独使用曲妥珠单抗组病理完全缓解率显著升高（53.3%：38.8%， RR =1.39，95%CI 为1.20~1.63，P ＜0.001）；Ⅲ~Ⅳ级不良反应方面，除了联合组的腹泻发生率更高（25.6%：2.2%，RR =11.54，95%CI 为5.69~23.41，P ＜0.001）以外，其他差异均无统计学意义。结论在 HER2阳性乳腺癌患者的新辅助治疗中采用新辅助化疗联合曲妥珠单抗、拉帕替尼的双重抗 HER2靶向治疗效果较好，且除了腹泻外并不提高其他不良反应发生率，是一种高效、安全的治疗选择。
Objective To compare the efficacy and safety of trastuzumab versus the combination of tras-tuzumab and lapatinib added to neoadjuvant chemotherapy in HER2-positive breast cancer. Methods We searched PubMed,MEDLINE,The Cochrane Library,Web of Science,CNKI,Wanfang datebase and the abstracts of major international conferences in recent 5 years to identify randomized controlled trials which met the inclusion and exclusion criteria. Study selection and analyses were undertaken according to the Cochrane Hand-book. Meta-analysis was performed using RevMan 5. 0 software. Results Four trials were identified with 779 eli-gible patients. The results of meta-analyses showed that the rate of pathological complete response was significant-ly higher in the group receiving rastuzumab and tlapatinib than that in the group with trastuzumab alone（53. 3%vs 38. 8% ,RR =1. 39,95 % CI：1. 20-1. 63;P 〈 0. 001）. No statistical differences were observed in regarding adverse events among patients receiving trastuzumab or the combination of trastuzumab and lapatinib,except the grade Ⅲ-Ⅳ diarrhea（2. 2% vs 25. 6% ,RR =11. 54,95% CI：5. 69-23. 41;P 〈0. 001）. Conclusion The com-bination of trastuzumab and lapatinib added to neoadjuvant chemotherapy in HER2-positive breast cancer is more effective,without more adverse reactions except diarrhea;it ia an effective and safe treatment.
出处
《国际肿瘤学杂志》
CAS
2015年第4期269-273,共5页
Journal of International Oncology
